Why Is the FDA Stalling on More Coronavirus Testing?
The coronavirus is coming yet the federal government’s response remains lackluster. Bizarrely, the Food and Drug Administration (FDA) has so far refused to green-light American labs’ attempts to test for the life-threatening illness, thereby prompting plenty of criticism and angry letters.
The Association of Public Health Laboratories has asked the agency for permission to develop tests for the virus, but their pleas have been met with persistent foot-dragging. The FDA’s frustrating risk aversion is nothing new, and things will not change absent a wholesale reevaluation of the agency’s mission. The country cannot wait for bureaucrats’ delay tactics.
The saga began on February 4, when the FDA announced that it had granted “emergency use authorization” to the Centers for Disease Control and Prevention (CDC) to test for coronavirus detection at qualified laboratories across the country. There have been a number of kinks in CDC testing, and currently, only a handful of states are even qualified to use it—California, Illinois, Nebraska, Nevada, and Tennessee. So while the CDC has been busy working out problems with the diagnostics, private labs are champing at the bit to develop their own tests. It’s up to the FDA to grant those labs the permission to make their own rival tests, yet there’s little indication that the agency intends to do that anytime soon.
By most accounts, the Food and Drug Administration’s (FDA) track-record in approving new products and testing procedures isn’t very good. The cost of bringing a new medication to market is now more than $2 billion and patients have to wait more than a decade to see life-saving drugs become available. Even if the FDA does finally get around to approving coronavirus testing, drug development to defeat the disease will prove prohibitively pricey thanks to agency regulations.
This is especially true for therapies aimed at rare diseases (that may not be so rare in the near future), because in many cases there aren’t enough patients to conduct a large trial. In a recent guidance, the agency acknowledged these issues, stating, “For rare diseases, there may be a limited number of patients who may qualify for enrollment into a clinical study. A single-arm trial using historical controls, sometimes including an initial observation period, may be considered if there are feasibility issues with conducting a randomized, controlled trial.”
But there are also plenty of drugs under FDA evaluation for common diseases and afflictions, and overall, the process remains far too difficult for manufacturers to get their products to patients.
Take, for example, the struggle of manufacturer AstraZeneca to get a new inhaler to market to treat chronic obstructive pulmonary disease (COPD). Already approved in Japan, the medication promises significant relief from an ailment that has no cure. Plenty of evidence has been produced showing that the experimental triple combination inhaler improves lung function and reduces flareups. But the FDA has likely rejected the drug because the most compelling evidence for PT010’s effectiveness came after AstraZeneca submitted their application to the agency.
The late-stage ETHOS trial found significantly improved quality of life for sufferers, yet the FDA wouldn’t budge because the results didn’t come out until after all the other clinical data were released and submitted. In other words, the FDA cares more about regulatory filing deadlines than patient well-being. According to a 2018 assessment from the Tufts Center for the Study of Drug Development, study protocol complexity is increasing to meet the tedious needs of the FDA “despite high industry awareness in the adverse impact that protocol complexity has on clinical trial performance….”
In other cases, the FDA seems to agree that the product under evaluation is safe and effective, but has some nitpick that sets the medication back months or years. In June 2018, Valeant Pharmaceuticals announced they’d received a “Complete Response Letter” (read: rejection) from the FDA for their medication (Duobrii) designed to treat plaque psoriasis. Never mind that Duobrii’s safety and effectiveness were confirmed in two large-scale peer-reviewed studies with more than 400 participants total. The FDA “noted questions regarding pharmacokinetic data” and delayed approval until April 2019.
Clearly, the FDA sees no urgency in approving medications and tests that are safe and effective in improving millions of lives. The agency needs to reevaluate its regulatory approach and the current coronavirus catastrophe offers a prime opportunity. The agency can be a force for good but only by letting innovators get life-saving medications and tests to market.
Ross Marchand is the director of policy of the Taxpayers Protection Alliance.